UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

Completed · Phase 1

Conditions studied: Malignant Melanoma

In brief

UV1 is a therapeutic cancer vaccine that has been explored in prostate and lung cancers, and in combination with ipilimumab in malignant melanoma. This study will explore the safety, tolerability and efficacy of UV1 administered with GM-CSF in melanoma patients who are also receiving pembrolizumab.

Key facts

Study ID

NCT03538314

Run by

Ultimovacs ASA

People needed

30

Starts

2018-07-09

Expected to finish

2024-06-15

Last updated by the study team

2024-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Uveal or ocular malignant melanoma
• History of hematologic or primary solid tumor malignancy with the exception of patients in remission for at least 5 years, as judged by the investigator are allowed
• Prior systemic treatment for unresectable or metastatic melanoma. Exception: Prior treatment with BRAF and MEK inhibitors permitted. A washout period of at least 3-half-lives (median terminal half-life) prior to the first dose of trial treatment must have elapsed.
• Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or oncolytic virus.
• Known hypersensitivity to GM-CSF
• Women who are breastfeeding, pregnant or expect to be pregnant during the study through 6 months after the last dose
• Men who plan to become a father during the study through 4 months after the last dose of study medication
• Known history of, or any evidence of active, non-infectious pneumonitis
• History of cardiac disease

Where it is running

• John Wayne Cancer Center — Santa Monica, California, United States
• University of Iowa Carver College of Medicine — Iowa City, Iowa, United States
• St. Luke's University Health Network — Easton, Pennsylvania, United States
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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